Drain placement following carotid endarterectomy (CEA) does not lower rates of perioperative death, stroke or return to the operating room (OR) for bleeding but is instead associated with prolonged hospital stay. So finds an analysis of nearly 48,000 patients from the Society for Vascular Surgery’s Vascular Quality Initiative (VQI) who underwent CEA with or without drain placement. The study was published in the Journal of Vascular Surgery (2020;72:204-208).
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“The results of this study have altered the way we view drains for CEA at Cleveland Clinic,” says the article’s lead and corresponding author, Christopher Smolock, MD, a Cleveland Clinic vascular surgeon. “I have switched from always placing a drain following carotid endarterectomy to rarely doing so.”
A common but unstudied practice
At many institutions, drains have been considered necessary after CEA to reduce hematoma formation and complications. As the study authors note, every surgeon has his or her own policy about placing them: Some do so routinely, some never do, and others do so depending on circumstances. Despite the fact that drain placement after CEA is a common practice, no evidence supports its use.
Study design and results
Dr. Smolock and colleagues from Cleveland Clinic searched the VQI registry to identify all patients who underwent CEA from 2011 to 2015. Of 47,752 patients identified, 19,425 (40.7%) had a drain placed and 28,327 (59.3%) did not.
Drain placement after CEA did not prevent the following two primary outcomes:
- Return to the OR for bleeding, which occurred in 0.83% of patients with no drain placement versus 1.0% of those with drain placement (P = 0.024 in favor of no drain placement)
- Postoperative wound infection, which occurred in 0.1% of patients with no drain placement versus 0.07% of those with drain placement (P = 0.42)
Moreover, hospital length of stay was found to be longer in patients with drain placement compared with no drain placement (2.4 ± 9.4 days vs. 2.1 ± 9.0 days; P < 0.001).
In addition, among patients who returned to the OR for bleeding, drain placement did not significantly affect rates of stroke, 30-day mortality, or combined mortality or stroke at 30 days, all of which were numerically lower among patients not receiving drain placement.
Among the overall cohort, the following factors were found to be significant predictors of returning to the OR for bleeding:
- Drain placement (P = 0.024)
- Chronic obstructive pulmonary disease (P = 0.024)
- Preoperative anticoagulant use (P < 0.001)
- Reexploration of the carotid artery after closure (P < 0.001)
- Preoperative P2Y12 antagonist use (P < 0.001)
- Absence of protamine use (P < 0.001)
The last three factors above — reexploration of the artery, preoperative P2Y12 antagonist use and lack of protamine use — were predictors of return to the OR for bleeding specifically among the subset of patients with drain placement.
Baseline differences didn’t change outcomes
Patients in the two study arms differed in some baseline and intraoperative factors. Those with drain placement were significantly more likely than those without to be male, to be taking a preoperative P2Y12 antagonist, to have had prior CEA or carotid artery stenting, to undergo a concomitant coronary bypass graft or other arterial procedure, to receive dextran, and to not receive protamine (P < 0.001 for each factor). Despite these differences, the major study findings remained unchanged after analysis of similarly matched patients.
CEA: a procedure with rare but high-risk consequences
Dr. Smolock notes that while bleeding events that required a return to the OR occurred in less than 1% of study patients, the potential consequences — i.e., stroke and death — can be devastating.
“Various strategies have been tried to reduce the chance that a patient will need to return to the OR, but many of these strategies have no evidence to back them up,” he says.
Although complication rates are low for drain placement, he adds, patient comfort and satisfaction — reflected in shorter hospital stays — are also important to consider.
According to Dr. Smolock, this study emphasizes that drains are not a substitute for hemostasis prior to operative closure.
In the past few years, Cleveland Clinic surgeons have more selectively placed drains after CEA, especially for reoperations and after complex operations involving an elevated risk of bleeding or other fluid leakage. “Selective drain placement has played a part in creating a care pathway for shortened length of stay,” Dr. Smolock notes. “We have reduced this length of stay from an average of 2.5 days to 1 day.”
Further research into CEA practice
He adds that a Cleveland Clinic research team is now evaluating the optimal timing of CEA within the treatment course for carotid artery stenosis and whether CEA might perhaps not be needed in some cases in which it is currently performed. The investigators will compare outcomes data from Cleveland Clinic patients with de-identified outcomes from other centers using the VQI registry.
“This study shows it’s worthwhile to examine practices that have become entrenched as standard of care based on good intentions rather than data,” observes Sean Lyden, MD, Chair of Vascular Surgery at Cleveland Clinic. “In the absence of data, it’s never a mistake to ask good research questions.”